A MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO ASSESS THE EFFICACY AND TOLERABILITY OF TWO DOSING REGIMENS OF ALLERT, A COMBINATION OF CONTIGUOUS OVERLAPPING PEPTIDES DERIVED FROM BET V 1, IN ADULTS WITH BIRCH POLLEN ALLERGIC RHINITIS/RHINOCONJUNCTIVITIS

INTERVENTION: Product Name: AllerT Pharmaceutical Form: Powder for injection INN or Proposed INN: not established CAS Number: none Current Sponsor code: AllerT1 Other descriptive name: AllerT1 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 17.15‐ INN or Proposed INN: not established CAS Number: none Current Sponsor code: AllerT2 Other descriptive name: AllerT2 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 25.55‐ INN or Proposed INN: not established CAS Number: none Current Sponsor code: AllerT3 Other descriptive name: AllerT3 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 19.80‐ Pharmaceutical form of the placebo: Powder for injection Route of administration of the placebo: Subcutaneous use Product Name: AllerT Pharmaceutical Form: Powder for injection INN or Proposed INN: not established CAS Number: none Current Sponsor code: AllerT1 Other descriptive name: AllerT1 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 3.43‐ INN or Proposed INN: not established CAS Number: none Current Sponsor code: AllerT2 Other descriptive name: AllerT2 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 5.11‐ INN or Proposed INN: not established CAS Number: none Current Sponsor code: AllerT3 Other descriptive name: AllerT3 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 3.96‐ Pharmaceutical form of the placebo: Powder for injection Route of administration of the placebo: Subcutaneous use CONDITION: Adult patients, 18‐65 years of age, suffering from moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons. ; MedDRA version: 19.1 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870 Therapeutic area: Diseases [C] ‐ Ear, nose and throat diseases [C09] SECONDARY OUTCOME: Secondary end point(s): Average of the total score of the quality of life questionnaires obtained weekly during the birch pollen season using the validated Mini‐RQLQ questionnaire ; Average of the Night‐time Nasal Symptom Score (NNSS) obtained daily during the birch pollen season ; Average of the combined Rhinoconjunctivitis and Night‐time Symptom and Medication Score (CNSMS) obtained daily during the birch pollen season ; Percent of Well Days during the birch pollen season ; Percent of Days with Severe Symptoms during the birch pollen season ; Subject’s global evaluation of treatment efficacy collected at the end of the birch pollen season both on a categorical scale as well as on a VAS Timepoint(s) of evaluation of this end point: Start day of birch pollen season until end day of birch pollen season. INCLUSION CRITERIA: 1. Men or women aged 18 to 65 years 2. Subjects presenting moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen confirmed at screening by all of the following criteria: a. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) = 12 during the two consecutive preceding birch pollen seasons based on subject’s interview by the investigator b. Previous use of anti‐allergy medications during the two preceding birch pollen seasons based on subject’s interview by the investigator c. Positive SPT to birch pollen extract (wheal = 5 mm larger than the diluent control) d. Positive specific IgE CAP test for Bet v 1 (= 3 kU/L) 3. Women of childbearing potential under continuous effective contraception during the treatment period a. This includes: established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods of contraception PRIMARY OUTCOME: Main Objective: To demonstrate the efficacy of a two months pre‐seasonal treatment with AllerT 50 µg maintenance dose compared to placebo in reducing symptoms of and medication use in allergic Rhinitis/Rhinoconjunctivitis during the following birch pollen season Primary end point(s): The primary efficacy variable is the average of the combined Rhinoconjunctivitis Symptom and Medication Score (CSMS) obtained daily during the birch pollen season. Secondary Objective: To demonstrate the efficacy of a two months pre‐seasonal treatment with AllerT 10 µg maintenance dose in reducing symptoms of and medication use in allergic Rhinitis/Rhinoconjunctivitis during the following birch pollen season; ; To evaluate the safety and tolerability of a two months pre‐seasonal treatment with AllerT at maintenance doses of 50 µg and of 10 µg; ; To evaluate the effects of a two months pre‐seasonal treatment with AllerT at maintenance doses of 50 µg and 10 µg during the following birch pollen season on:; o Subjects' quality of life; o Other clinical endpoints including night‐time symptoms, number of well days, number of days with severe symptoms and subject’s global evaluation of treatment efficacy Timepoint(s) of evaluation of this end point: Start day of birch pollen season until end day of birch pollen season.